Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

22 male patients with metastatic prostate cancer and rising Prostate Specific Antigen (PSA) levels were recruited from 11th June 2003 (last subject completed on 31st October 2005). This study was conducted in 2 centres in the United States.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

6 of the 22 screened patients were not entered into the study as they did not fulfill the study eligibility criteria.

Reporting Groups

Description

ZD4054 10 mg

ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily

ZD4054 15 mg

ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily

ZD4054 22.5 mg

ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily

Participant Flow for 2 periods

Period 1: Period 1: Dose Escalation Period

ZD4054 10 mg

ZD4054 15 mg

ZD4054 22.5 mg

STARTED

3

10 [1]

3 [1]

COMPLETED

3

8

0

NOT COMPLETED

0

2

3

Adverse Event

0

1

2

Erroneously reported discont. criteria

0

0

1

Disease progression

0

1

0

[1]

Dose level given only after lower dose was successfully administered.

Period 2: Period 2: Extension Period

ZD4054 10 mg

ZD4054 15 mg

ZD4054 22.5 mg

STARTED

3 [1]

6 [2]

0

COMPLETED

3

6

0

NOT COMPLETED

0

0

0

[1]

Period 2 - attend Pts who,in the opinion of the Investigator,show benefit from treatment with ZD4054

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2).

Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100

Time Frame

Baseline to Day 15.

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

One patient received one dose of 22.5 mg and was dose reduced to 15 mg thereafter. This patient was classified into the 15 mg dose group, except for the single dose pharmacokinetic results (not posted).